Smoldering Plasma Cell Myeloma Clinical Trial
Official title:
Phase 2 Trial of Leflunomide in Patients With High-Risk Smoldering Multiple Myeloma
This phase II trial studies how well leflunomide works in treating patients with high-risk smoldering multiple myeloma. Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the anti-myeloma activity of leflunomide, when given as a single agent, as
assessed by freedom from progression at 2-years.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of single agent leflunomide. II. To summarize and
assess toxicities by type, frequency, severity, attribution, time course and duration.
III. To estimate overall and progression-free survival probabilities. IV. To estimate
response rate and duration of response. V. To describe the impact of treatment on quality of
life, as assessed by the European Organization for Research and Treatment of Cancer Quality
of Life Questionnaire (EORTC QLQ-C30) Score version (v)3.0.
EXPLORATORY OBJECTIVES:
I. To characterize the molecular evolution of the tumor cells. II. To evaluate whether
specific genetic subtypes respond differently to leflunomide.
III. To evaluate the role of immune cells in the progression of smoldering multiple myeloma
(SMM).
IV. To evaluate the role of leflunomide in modulating the immune system. V. To examine the
relationship between immunological changes and disease progression.
OUTLINE:
Patients receive leflunomide orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 28 days.
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